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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device software for diagnosis/treatment
Definition Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions
Product CodeOSN
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ARROWHEAD MEDICAL DEVICE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 3 3
2019 1 1
2020 1 1
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Problem 5 5
Computer Software Problem 2 2
Device Difficult to Program or Calibrate 2 2
Communication or Transmission Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Information 2 2
Insufficient Information 1 1
No Consequences Or Impact To Patient 1 1
Injury 1 1
Inadequate Osseointegration 1 1
No Known Impact Or Consequence To Patient 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew, Inc. II Jan-08-2018
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